Last updated: 11/03/2018 23:23:19
A study to evaluate persistence of immune responses after post-exposure prophylaxis of Rabipur® (purified chicken-embryo cell Rabies vaccine) in Chinese Children
GSK study ID
205634
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A phase IV, open label, single-center extension study, to evaluate the long-term persistence of immune responses after post-exposure prophylaxis with purified chicken-embryo cell rabies Vaccine in Chinese children
Trial description: The purpose of this study is to evaluate the long-term persistence of immune responses approximately 5 years or more after simulated rabies post-exposure prophylaxis provided in 2012 according to Essen (1-1-1-1-1) or Zagreb (2-1-1) intramuscular (IM) regimens in the subset of subjects who participated in the parent study (V49_24 [NCT01680016]) who were aged ≥6 and ≤17 years at the time of enrollment. This study is aimed to respond to a post-marketing commitment by the China Food and Drug Administration (CFDA) requested at the time of the renewal of the purified chicken-embryo cell rabies vaccine license in China, granted in August 2015.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Rabies Virus Neutralizing Antibody(RVNA) GMCs as measured by rapid fluorescent focus inhibition test(RFFIT) measured in the study, following the Post-Exposure Prophylaxis(PEP) received in the V49_24 (NCT01680016) parent study (Zagreb and Essen regimens).
Timeframe: Day-1/Visit-1
Percentage of subjects with RVNA concentration ≥ 0.5 IU/mL measured in this study, following the PEP received in the V49_24 (NCT01680016) parent study (Zagreb and Essen regimens).
Timeframe: Day-1/Visit-1
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
150
Primary completion date:
2017-12-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Virus Diseases
Product
GSK3536851A
Collaborators
Not applicable
Study date(s)
December 2016 to March 2017
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
10 - 22 years
Accepts healthy volunteers
Yes
- 1. Subjects with age ≥ 6 and ≤17 at the time of enrollment in the parent study who signed the informed consent prior to the extension study entry, who received the full PEP in the parent study according to either the Zagreb or Essen intramuscular regimens.
- 2. Subjects who or whose parent(s)/legal guardian(s) have voluntarily given written informed consent/assent for this extension study after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Prior to extension study entry, each subject must not have:
- 1. Documented medical history of exposure to rabies or rabies prophylaxis after completion of the parent study (V49_24 [NCT01680016]) and before study start.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Subjects with age ≥ 6 and ≤17 at the time of enrollment in the parent study who signed the informed consent prior to the extension study entry, who received the full PEP in the parent study according to either the Zagreb or Essen intramuscular regimens. 2. Subjects who or whose parent(s)/legal guardian(s) have voluntarily given written informed consent/assent for this extension study after the nature of the study has been explained according to local regulatory requirements, prior to study entry. 3. Individuals who can comply with study procedures.
Exclusion criteria:
- Prior to extension study entry, each subject must not have: 1. Documented medical history of exposure to rabies or rabies prophylaxis after completion of the parent study (V49_24 [NCT01680016]) and before study start. 2. Participated in the parent study (V49_24 [NCT01680016]) but not received the full PEP vaccination course (or received it out of window) following assignment to either Zagreb or Essen regimen during the parent study. 3. Progressive, unstable or uncontrolled clinical conditions. 4. Clinical conditions representing a contraindication to blood draws. 5. Abnormal function of the immune system resulting from: a. Clinical conditions. b. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to informed consent for all age groups. c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent for all age groups. 6. Received immunoglobulins or any blood products within 180 days prior to informed consent for all age groups. 7. Study personnel as an immediate family or household member. 8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
2017-12-03
Actual study completion date
2017-12-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website